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ICH Q8: QbD in Manufacturing

ICH Q8: QbD in Manufacturing

This course provides a comprehensive overview of Quality by Design (QbD), emphasizing its science-and-risk-based methodology with a patient-centric focus specifically tailored to enhance manufacturing processes. Participants will gain a thorough understanding of QbD terminology, key steps, and the advantages it offers. Additionally, it covers regulatory and industry guidelines, offering valuable insights into linking QbD with the Process Validation lifecycle, including references to influential resources such as the ISPE PQLI Guides.
300.00